Newborn Screening - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts 2019 - 2029

The Global Newborn Screening Market size is estimated at USD 1.29 billion in 2024, and is expected to reach USD 1.97 billion by 2029, growing at a CAGR of 8.90% during the forecast period (2024-2029).

The COVID-19 pandemic affected every aspect of the healthcare system around the world due to the high influx of COVID-19 patients owing to the high infectivity rate of the SARS-COV-2 virus. The newborn screening procedures were also impacted initially due to the diversion of resources towards COVID-19 management which is anticipated to have an impact on the market. For instance, according to a research study titled 'Global impact of COVID-19 on newborn screening programs' published in March 2022, most newborn screening centers responded that the pandemic created little effect (47.7%), 18.6% a moderate effect, and 12.8% a lot, while 16.3% of the centers reported no effect. Also, as per the same source, in 29 of the 38 countries that responded, COVID-19 had some effect on the newborn screening programs and most of the screening centers encountered a wide range of issues, and the majority were more negatively impacted by the pandemic's second wave. Hence, COVID-19 is expected to have a significant impact on the newborn screening market.

Factors responsible for the growth of the newborn screening market include growing newborn screening programs, rising incidences of congenital diseases, raising funding from government sectors for newborn screening, and advancements in technologies used in newborn screening. For instance, according to a research study published in April 2022, titled 'Epidemiology of Congenital Heart Disease in Jinan, China From 2005 to 2020: A Time Trend Analysis', in urban regions, the prevalence of congenital heart disease (CHD) was 4.81 per 1,000 births from 2005 to 2020, compared to 3.17 per 1,000 births in rural areas and the prevalence of CHD grew by 157.45% and 316.03%, respectively, in urban and rural areas between 2005 and 2020, according to a time trend analysis of the data. Similarly, according to the February 2022 data of the World Health Organization, an estimate, birth abnormalities are responsible for the death of about 240,000 newborns in the first 28 days of life each year across the glove and an additional 170,000 children between the ages of 1 month and 5 years die because of birth abnormalities. Hence, newborn screening becomes very important as it can provide a proper health analysis of newborns in determining various birth defects or diseases, which can be used to provide adequate medical attention to the newborn and save the life of the newborn. Thus, the demand for newborn screening is expected to increase which will fuel growth in the studied market over the forecast period.

Further, the newborn screening programs run by governments across the continent are expected to have a significant impact on the growth of the newborn screening market as several governments have made newborn screening compulsory before getting discharged from the hospital. For instance, according to the March of Dimes (MoD) report of 2021, before leaving the hospital, every baby in the United States receives newborn screening and the nation screens around 4 million newborns annually. Moreover, the technological advancement in newborn screening platforms and devices is also expected to have a significant positive impact on the newborn screening market over the forecast period. However, the lack of uniformity in newborn screening policies and procedures across the world, and a high number of false positive and false negative results from the tests are expected to restrain the newborn screening market during the forecast period.

Newborn Screening Market Trends

Dried Blood Spot Segment is Expected to Hold the Major Share in the Market Over the Forecast Period

The COVID-19 pandemic has created a massive demand for DBS newborn screening tests, which has led to the development of novel NBS tests during the pandemic. In July 2020, PerkinElmer Inc. launched a dry blood spot (DBS) based test for SARS-CoV-2 IgG using its GSP/DELFIA platform, enabling the processing of up to 5,000 samples per day. The DBS assay runs on PerkinElmer's GSP analyzer and, combined with the universal TRF (time-resolved fluorescence) of the DELFIA platform, screens more than 30% of all newborn babies worldwide, spanning 32 countries.

Dried blood spot tests (DBS) are expected to continue their domination during the forecast period. DBS sampling has been used to screen newborn babies for congenital metabolic diseases for over 50 years. The advantages of DBS sampling include minimal volume requirements (approximately 30 - 100 µL per spot), ease of sample attainment by finger or heel stick with minimal training required, and ease of transport and sample stability. Autism, lymphomas, leukemia, and many other metabolic conditions can be diagnosed through this test. Dried blood spot analysis offers the advantage of collecting a small sample volume, which can be easily transported. Thus, rising diseases in newborns are boosting market growth.

Additionally, few organizations and Academic institutes in the segment have been developing novel products and technologies to compete with the existing products. For instance, in March 2022, Oxford University initiated a population-based newborn screening study in the Thames valley. The screening will be done through the routine United Kingdom newborn blood spot screening pathway, using spare capacity from a newborn's Guthrie card (dried blood spot sample). Thus the factors mentioned above are expected to drive the growth of the studied segment during the forecast period.

North America Region is Expected Occupy Major Share in the Market Over the Forecast Period

The North American region is expected to hold a major share in the newborn screening market owing to the high burden of birth defects in the region, government policies, the presence of robust healthcare infrastructure, and new technological developments in newborn screening technology by the players based in the region. For instance, according to a research study published in April 2022, titled 'Association of Birth Defects with Child Mortality Before Age 14 Years', birth defects were strongly associated with mortality owing to circulatory, respiratory, and digestive causes and the finding raises the possibility that the role of birth abnormalities in mortality numbers may be understated. The study was conducted in Canada and as per the same source, birth defects such as heart problems, chromosomal anomalies, and central nervous system disorders all increased the chance of death by more than ten times, eight times, and seventeen times, respectively, and the risk of death was significantly higher between days 28 and 364 of life, however, it was also higher at other times. Hence the demand for newborn screening in the region is expected to increase over time and the market is expected to grow in the region.

In the North American region, the United States is anticipated to hold the largest market share. This can be attributed to the increasing incidence rates of disorders in newborns and the rising demand for advanced systems. In the United States, every newborn is screened post-birth, and this screening is performed by the analysis of diagnostic markers in blood spots collected on filter paper on the second day of an infant's life. Newborn screening programs are run on a state basis within the United States; therefore, it has been observed that there is a lack of uniformity among the testing panels of many states. For instance, according to the data published by the Centers for Disease Control and Prevention, in 2022, about 3,613,647 new births were reported in the country, and the birth rate in the country 2022 was 11.0 per 1,000 population, and most of these birth in hospitals, thus, the screening is performed before babies' discharge. Further, the launch of new services and products in the region is expected to have a significant impact on the growth of the studied market. For instance, in June 2021, the Texas Health and Human Services launched newborn screening for Spinal Muscular Atrophy (SMA). Therefore, due to the above-mentioned factors, the newborn screening market is expected to have a significant market share over the forecast period.

Newborn Screening Industry Overview

The newborn screening market is moderately competitive and consists of several major players. In terms of market share, few of the major players currently dominate the market. Some of the of key players in the market are Agilent Technologies Inc., Natus Medical Inc., Trivitron Healthcare, Medtronic Inc., Masimo Corp., and Bio-Rad Laboratories Inc., among others.

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